Last updated: 11/03/2018 10:56:45

Immunogenicity and reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in people 18 years old or above

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GSK study ID
110221
See study documents
Clinicaltrials.gov ID
NCT00476307
EudraCT ID
2007-001828-12
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in people aged 18 years or above
Trial description: This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Fluarix™/Influsplit SSW® 2007/2008
    • Enrollment:
    120
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    SB218352
    Collaborators
    Not applicable
    Study date(s)
    June 2007 to July 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Healthy male or female aged 18 years or above;
    • Non-childbearing or using adequate contraception;
    • Subjects must not:
    • Participate in a trial or using non-registered product;
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male or female aged 18 years or above;
    • Non-childbearing or using adequate contraception;
    • Written informed consent obtained from the subject.
    Exclusion criteria:
    • Subjects must not:
    • Participate in a trial or using non-registered product;
    • Use immunosuppressants, blood products, or another influenza vaccine during study;
    • Have virologically confirmed influenza within 1 year;
    • Have allergic or acute disease;
    • Have unstabilized serious chronic disease;
    • Be a lactating female.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01099
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Freital, Sachsen, Germany, 01705
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01307
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-11-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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